A Study to Learn if 27T51, a Mucin-16 (MUC16) Protein Targeting Immune Cell Therapy, Administered Alone or in Combination is Safe and How Well it Works for Adult Participants With Recurrent or Treatment Resistant Ovarian Cancers

Launched by REGENERON PHARMACEUTICALS · Jun 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called 27T51, which is a type of immune cell therapy designed to help fight certain types of ovarian cancer, including epithelial ovarian cancer, primary peritoneal carcinoma, and fallopian tube cancer. The researchers want to learn if this therapy is safe and how well it works, particularly for women whose cancer has come back or has not responded to other treatments. The trial has two main parts: the first will test different doses of the treatment to find the highest safe dose, and the second will give that established dose to more participants, possibly alongside other medications.

To be eligible for this study, participants should be adult women aged 18 or older with a specific diagnosis of one of the targeted cancers and must have measurable tumors. They should also have a good performance status, meaning they are generally well enough to participate. However, individuals with certain health issues or recent autoimmune diseases may not qualify. Participants can expect to receive close monitoring during the trial and contribute to important research that could lead to new treatment options for ovarian cancer.

Gender

FEMALE

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• • 2. Histological diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube cancer according to World of Health Organization (WHO) 2020 classification
• • 3. Recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer, as described in the protocol
• • 4. Serum cancer antigen (CA) 125 ≥ 2 × upper limit of normal (ULN) as assessed at the local lab by a 510(k) cleared test at screening
• • 5. Participants must have at least 1 measurable tumor lesion as defined by the response evaluation criteria in solid tumors (RECIST) 1.1.
• • 6. Expected survival ≥ 3 months
• Key Exclusion Criteria:
• • 1. Inadequate cardiovascular, renal and hepatic function, as described in the protocol
• • 2. Absolute lymphocyte count (ALC) \< 100 cells/μL at time of leukapheresis
• • 3. History of Grade ≥ 2 hemorrhage within 30 days, or inadequate coagulation parameters, as described in the protocol
• • 4. Known history or presence of clinically relevant central nervous system (CNS) pathology, as described in the protocol
• • 5. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune related adverse events (AEs)
• • 6. Treatment with any cellular or gene therapy
• • Note: Other protocol-defined Inclusion/Exclusion criteria apply